Back to resultsThe Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
Primary Purpose
Myopia, High Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Home training
School training
Sponsored by
About this trial
This is an interventional prevention trial for Myopia
Eligibility Criteria
Inclusion Criteria: All students in grades 1 to 4 Can cooperate with the examination of students Exclusion Criteria: Obvious strabismus and amblyopia Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases History of ocular surgery
Sites / Locations
- Tiajin Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Home-school training group
School training group
No training group
Arm Description
There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.
There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.
There was no such treatment for students.
Outcomes
Primary Outcome Measures
The rate of new-onset myopia
The number of new children with myopia was counted
The changes of refractive error
The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
The changes of axial length
The axial length was measured by a biological measuring instrument.
Secondary Outcome Measures
Full Information
NCT ID
NCT05691296
First Posted
December 25, 2022
Last Updated
January 11, 2023
Sponsor
Tianjin Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05691296
Brief Title
The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
Official Title
The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.
Detailed Description
The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, High Myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-school training group
Arm Type
Experimental
Arm Description
There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.
Arm Title
School training group
Arm Type
Experimental
Arm Description
There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.
Arm Title
No training group
Arm Type
No Intervention
Arm Description
There was no such treatment for students.
Intervention Type
Behavioral
Intervention Name(s)
Home training
Intervention Description
Letter Chart Accomodative Rock Training for 2 minutes each time
Intervention Type
Behavioral
Intervention Name(s)
School training
Intervention Description
Letter Chart Accomodative Rock Training for 2 minutes each time
Primary Outcome Measure Information:
Title
The rate of new-onset myopia
Description
The number of new children with myopia was counted
Time Frame
Through study completion, an average of 1 year
Title
The changes of refractive error
Description
The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
Time Frame
Every 6 months, up to 3 years
Title
The changes of axial length
Description
The axial length was measured by a biological measuring instrument.
Time Frame
Every 6 months, up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All students in grades 1 to 4
Can cooperate with the examination of students
Exclusion Criteria:
Obvious strabismus and amblyopia
Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
History of ocular surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Yang, MD
Phone
+86-22-27306525
Email
yanzitjsykyy@163.com
Facility Information:
Facility Name
Tiajin Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Yang
Phone
+862227306525
Email
yanzitjsykyy@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
33909032
Citation
Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6.
Results Reference
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Learn more about this trial
The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
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